Product Engineer II (northridge, CA)

Job Opportunity at Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

This position involves performing chemical characterization in alignment with biocompatibility assessments, organizing and coordinating required testing, and preparing clear, concise, and well-structured test plans and reports to support regulatory submissions. This role involves coordinating required chemical characterization testing, and authoring clear, concise, and well-structured reports to support regulatory submissions. This position involves close collaboration with multidisciplinary and cross-functional teams to ensure compliance with ISO 10993 standards and global medical device regulations. The role also supports product development by designing and executing design verification test methods and conducting statistical data analysis to assess product performance and functionality. The candidate is expected to contribute to scientific presentations and author relevant technical publications as needed. This position is an exciting opportunity to work with Medtronic’s Diabetes business.

Responsibilities may include the following and other duties may be assigned:

• Perform chemical characterization in alignment with biocompatibility assessments, organizing and coordinating required testing, and preparing clear, concise, and well-structured test plans and reports to support regulatory submissions.
• Provide technical documentation supporting biological assessments of material and device safety in accordance with ISO 10993-1 by conducting chemical characterization analysis impact assessments for changes in materials, processes, or intended uses of devices.
• Perform technical feasibility and design verification activities in a product development environment, including chemical characterization analysis, toxicological risk assessments, materials of concern (MOC) in collaboration with department staff and contract laboratories.
• Interpret chemical characterization data to integrate into the Biological Evaluation Report (BER), preparing devices for submission to internal and external laboratories, maintaining good documentation practices, and ensuring accurate records of original information.

Minimum requirements:

• Requires a Bachelor’s degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Nice to haves:

• BS in science, medical technology, or related fields. MS or PhD preferred.
• Strong skills in design of experiments, data analysis, written and verbal communications, and collaboration.
• Critical thinking skills to interpret available data and recommend strategies to resolve technical challenges.
• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
• Author, execute, review, and approve protocols, reports, and/or regulatory submissions pertaining to chemical characterization per ISO 10993-12, 17 and 18.
• Provide objective assessment through critical review, interpretation and analysis of raw data, clinical relevance, toxicological risk assessments and trending.
• Root cause(s) and efficient recommendations for resolution.
• Must be self-motivated and able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced environment.

Physical job requirements:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD): $80,000.00 - $120,000.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.